A revolutionary class of drugs with the potential to treat intractable diseases like cancer and other killers — as well as to explode health spending globally — is at the center of the toughest negotiations of the biggest trade deal in history.

The pharmaceutical industry has been pressing the Obama administration to insist that the Trans-Pacific Partnership include 12 years of monopoly pricing power for the makers of these complex and costly drugs. But critics and international relief organizations warn that the deal would lock in higher costs and mean that far fewer people in developing countries would be able to afford life-saving medication.

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For lawmakers opposed to giving broad trade-negotiating authority to the administration, the drug dispute highlights the danger of setting policies on life-and-death matters through a mostly closed-door process.

“This deal is being negotiated largely in secret, but what we do know is that the pharmaceutical and financial industries have had a heavy hand in the process, and nothing good can come from that,” Rep. Louise Slaughter, a New York Democrat, said Thursday. “This kind of outsized influence on the trade process hurts everyone involved.”

The provision allowing drug companies such lengthy protection is unanimously opposed by the other 11 nations that would be party to the Trans-Pacific Partnership. Yet with the backing of many Republicans and some Democrats, major pharmaceutical companies and their trade groups have thrown down the gauntlet. They insist they’re standing firm on the 12-year provision for biologics, as these highly promising drugs are known. As organic products derived from living cells, they’re typically injectable — in contrast to the traditional prescription pills most consumers get at the pharmacy.

The industry recently garnered a letter supporting the full 12 years of exclusivity from Ohio Sen. Rob Portman, a former U.S. trade representative under President George W. Bush, and 10 fellow Republicans. They cited the “substantial investment” needed to “offer new hope to patients suffering from cancer, arthritis and rare diseases.”

Some trade-deal supporters go so far as to say they would rethink their support if biologics don’t get the full protection.

“I’ll be very upset,” Utah Sen. Orrin Hatch told POLITICO. “I’d have a rough time supporting the bill.”

The Obama administration has given mixed signals.

As part of the Affordable Care Act, the White House acceded to industry requests for a dozen years of exclusivity for biologics. Since then, however, the administration has repeatedly tried through budget proposals to cut the period to seven years. If the administration were to agree to a dozen years in the trade talks, it would lock in that period at home, too.

U.S. negotiators adopted the 12-year term as their initial position but are facing strong opposition from the other Pacific Rim countries. In Washington, many Democrats and the AARP oppose such a long period of exclusivity based on the same concerns of affordability and access abroad as well as at home.

Trade Representative Michael Froman, who declined a request to comment for this story, has noted that there are huge differences in monopoly protection for drug manufacturers among TPP participants, with all other nations’ terms shorter than the U.S. period.

“Around the table, you have five countries that have zero years, four countries that have five years, two countries that have eight years, and we’re 12 years,” Froman testified at a Senate Finance Committee hearing in April.

The TPP trade deal aims to be the largest ever, covering more than 40 percent of the world’s gross domestic product. Protections for pharmaceutical companies are only some of many broad intellectual property rules the agreement would establish. Movie studios, publishers and software companies all have a stake in rules that would set the global standard for decades to come.

The drug industry says it needs the extended protection to recoup the extremely high costs of developing biologics.

“Congress originally came up with 12 years because they agreed that this is what was needed to make sure the medicines get to the market as quickly as they can,” said Mark Grayson, a spokesman for the Pharmaceutical Research and Manufacturers of America.

Young women suffering from tuberculosis wait to receive their medication at a Medecins Sans Frontieres-run clinic in Nairobi. | Getty

But even as drug company executives reaffirmed their position last month at a PhRMA meeting, an industry source said many were taking a broader view of how the overall deal would benefit them. “I think potentially at the end of the day, we have to look at the totality of the agreement,” he said. “Are we at a better place or a worse place?”

Despite the public pressure for the 12-year lockout, two industry lobbyists said an eight- or nine-year period may be the most that the industry can realistically expect. Some Democrats are pushing for just five years, the same as was given for traditional medications in a 2007 trade deal negotiated under the Bush administration. A House Democratic aide familiar with the negotiations said that seven years would likely be acceptable, though — since that’s the Democrats’ current target for U.S. law.

The length of the exclusivity period isn’t the only consideration for biologics. Also in play are provisions about when countries will have to comply with the new standards. The definition of exactly what constitutes a biologic drug is also on the table.

The stakes are huge. Sales of biologics were $130 billion worldwide in 2013 and are projected to hit $290 billion by 2020, according to Deloitte. And while drug makers often have patents that are longer than the government-sanctioned monopolies they get under U.S. law after a product is approved, those patents aren’t always honored internationally, especially in developing countries. The guaranteed monopoly pricing would be an added defense against weaker patent laws abroad.

But nongovernmental relief groups including OxFam, Doctors Without Borders and amFar, the Foundation for AIDS Research, have protested that the trade deal could make the drugs unaffordable for many poorer countries — even after accounting for the lower prices that manufacturers regularly negotiate outside of the United States. Doctors without Borders mounted an advertising campaign in D.C.-area Metro stations last month to decry TPP as “a bad deal for medicine.”

“It’s a question of our statement to the world about whether we care about them having access to medicine,” Democratic Rep. Jim McDermott of Washington said Thursday.

Other critics point to the potential impact closer to home, where changing the amount of time biologics have the market to themselves could also have major economic consequences. The White House estimates that capping the monoply term at seven years would save $4.5 billion in spending over a decade just for federal health care programs.

On the other side, enshrining 12 years in the trade deal would block any future efforts to cut back the protection that was written into the ACA.

“Yes, BIO and PhRMA won in 2010,” Generic Pharmaceutical Association CEO Ralph Neas said, referring to the two biggest industry trade groups. “The important point here is that if BIO and PhRMA get their way in the TPP … then that 12 years would be permanent. That’s why they’re fighting so hard on this.”

With the TPP trade ministers expected to bring negotiations to a close by early July, the protection provision must be resolved soon. Before that happens, President Barack Obama will have to secure fast-track legislation pending in Congress, which would allow him to submit an unamendable trade agreement for an up-or-down vote. Many countries are reluctant to offer their own bottom lines until they know the deal won’t get picked apart by U.S. lawmakers.

Representative Sander Levin (D-Mich.), the ranking member of the House Ways and Means Committee, said he fears the TPP discussions are moving “in the wrong direction” and eroding the progress reflected in that 2007 trade deal.

That pact “struck the right balance on medicines between the need to promote innovation and the need to protect public health,” Levin said in a statement. “This is the wrong time for Congress to give up its leverage … This issue is too important to lives around the globe to fast-track the wrong approach in TPP.”